MAUDE Adverse Event Report: SYMMETRY SURGICAL, INC. CLASSIC PLUS; WIRE, NEEDLE DRIVER

Model Number SYMMETRY 36-2025

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 08/26/2019

Event Type  malfunction  

Event Description

At the conclusion of the procedure, when placing the sternal wires, the "insert" from the sternal wire needle driver became dislodged from the instrument and was retained in the patient's chest.Per x-ray, the patient underwent an additional surgery to partially reopen the chest wall.As a result, the patient remained at the hospital for two additional inpatient admission days.The patient was discharged at his baseline.

• Brand Name: CLASSIC PLUS
• Type of Device: WIRE, NEEDLE DRIVER
• Manufacturer (Section D): SYMMETRY SURGICAL, INC.; 3034 owen dr; antioch TN 37013
• MDR Report Key: 9346886
• MDR Text Key: 167171894
• Report Number: 9346886
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2019,10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SYMMETRY 36-2025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Weight: 11